Cook Inc. Recalls Percutaneous Gastrostomy Sets Due to Wire Guide Defect
Cook Inc. is recalling 615 units of Mallinckrodt Institute Percutaneous Gastrostomy Sets because wire guides may be loaded backwards into the holder.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a medical device used for invasive procedures where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Cook Inc. is recalling 615 units of the Mallinckrodt Institute Percutaneous Gastrostomy Set. These medical devices are intended for the percutaneous placement of a catheter for gastroenteric feeding. The recall covers specific lots distributed nationwide in the United States.
The recall was initiated because Cook Inc. identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder. This defect could potentially interfere with the proper use of the device during the placement procedure.
Healthcare providers and patients who have these specific products should stop using them and contact Cook Inc. for further instructions. The affected lot numbers are 6869315, 6908857, 7034661, 7106057, 7193431, 7252317, 7635697, 7744001, 7811587, 8025220, and 8076495.
The recalled product
- Product
- Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Gastrostomy
- Affected units
- 615
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Cook Inc.
See all →- HighSkinny Needle with Chiba Tip recalled for debris contamination
FDA (Devices) · 2021-12-29
- HighCook Flexor Check-Flo Introducer recalled for size mislabeling
FDA (Devices) · 2021-12-22
- ModerateFlexor Check-Flo Introducer Recalled for Mislabeled Caliber Size
FDA (Devices) · 2021-12-22
- HighTransseptal Needles Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
- HighTransseptal Needle with Catheter Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
Same hazard · device defect
See all →- SevereBard Access Systems Recalls Power-Trialysis Dialysis Catheters
FDA (Devices) · 2026-09-23
- SevereBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
FDA (Devices) · 2026-07-22
Similar recalls
- HighCook Inc. Recalls Percutaneous Entry Sets Due to Wire Guide Loading Error
FDA (Devices) · 2020-02-12
- HighCook Inc. Recalls Percutaneous Malecot Nephrostomy Sets Due to Wire Guide Loading Error
FDA (Devices) · 2020-02-12
- HighCook Inc. Recalls Urethral Dilator Sets Due to Wire Guide Loading Error
FDA (Devices) · 2020-02-12
- HighCook Inc. Recalls Kwart Retro-Inject Ureteral Stent Sets
FDA (Devices) · 2020-02-12
- HighCook Inc. Recalls Angled Tip Ureteral Catheter Sets Due to Loading Defect
FDA (Devices) · 2020-02-12
- HighCook Inc. Recalls Angled Tip Ureteral Catheter Sets Due to Loading Error
FDA (Devices) · 2020-02-12